BONE PLUS BCP

K090950 · Megagen Implant Co., Ltd. · LYC · Jul 2, 2010 · Dental

Device Facts

• Record ID: K090950
• Device Name: BONE PLUS BCP
• Applicant: Megagen Implant Co., Ltd.
• Product Code: LYC · Dental
• Decision Date: Jul 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. - Augmentation or reconstructive treatment of alveolar ridge . - . Filling of periodontal defects - Filling of defects after root resection, apicocectomy, and cystectomy . - Filling of extraction sockets to enhance preservation of the alveolar ridge . - Elevation of maxillary sinus floor ● - Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration

Device Story

Bone Plus™ BCP is a synthetic, resorbable, osteo-conductive bone graft substitute. Composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate; features interconnected porosity mimicking human cancellous bone. Supplied sterile for single-use in dental/oral surgery. Clinicians apply the material to fill periodontal or bony defects, extraction sockets, or to augment the alveolar ridge and maxillary sinus floor. May be used adjunctively with GTR/GBR products. Acts as a scaffold to support bone regeneration; resorbs over time. Benefits include structural support for bone healing in oral/maxillofacial defects.

Clinical Evidence

Evidence includes bench testing (chemical/physical analysis, porosity assessment, solubility test) and a clinical study. Histomorphometric evaluation performed to assess bone regeneration performance.

Technological Characteristics

Synthetic bone graft substitute; 60% Hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate (beta-TCP). Interconnected porosity structure. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for patients requiring filling, augmentation, or reconstruction of periodontal or bony defects in the oral and maxillofacial region, including alveolar ridge augmentation, extraction socket preservation, and maxillary sinus floor elevation.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• MBCP™ (K051885)
• Cerasorb® Dental (K051443)
• Bio-Oss Collagen (K974399)

Submission Summary (Full Text)

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K090950

# JUL--2 2010

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#### 510(K) Summary

Submitter MegaGen Implant Co., Ltd. Seung Kyu Park 377-2 Gyochon-Ri, Jain-Myeon, Gyeongsan-Si, Gyeongbuk, South Korea Phone: [phone] Fax: [phone]

Official Correspondent Kodent Inc. Eugene Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: [e-mail] Phone: [phone] Fax: [phone]

Device Information

Trade name: Bone Plus™ BCP

Common name: Bone grafting material

Classification name: Bone Grafting Material, Synthetic

Classification product code: LYC

Regulation number: 872.3930

Device class: Class II

#### Device Description

Bone Plus™ BCP is a synthetic resorbable osteo-conductive bone graft substitute composed of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (beta-TCP). Bone Plus™ BCP presents a interconnected porosity structure, similar to that of human cancellous bone. It is supplied sterile and it is dedicated for single use.

#### Indication for Use

Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

- Augmentation or reconstructive treatment of alveolar ridge .
- . Filling of periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor ●

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- Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration

#### Device Type

- Bone Plus™ BCP Needle Graft. .
#### Materials

Bone Plus™ BCP is comprised of 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (f9-TCP)

#### Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

- MBCP™ (K051885) manufactured by Biomatlante Co., Ltd. .
- Cerasorb® Dental (K051443) manufactured by Curasan AG .
- Bio-Oss Collagen (K974399) manufactured by Geistlich-Pharma .

## Comparison to Predicate Devices

Testing and other comparisons have established that the subject of Bone Plus™ BCP substantially equivalent in design, materials, indications and intended use, and performance to other predicate devices of the type currently marketed in the U.S.

- . Histomorphometric Evaluation of Bone Plus™ BCP
- Chemical and Physical Analysis of Bone PlusTM BCP .
- Porosity assessment of Bone Plus™ BCP ●
- Solubility Test of Bone Plus™ BCP .
- Clinical Study of Bone Plus™ BCP .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Megagen Implant Company, Limited C/O Ms. Joyce Bang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs California 90670

JUL - 2 2010

Re: K090950

Trade/Device Name: Bone Plus BCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 20, 2010 Received: June 22, 2010

Dear Ms. Bang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2- Ms. Bang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

# 510(K) Number (if known): K090950

Device Name: Bone Plus™ BCP

Indication for Use:

Bone Plus™ BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, and cystectorny ?
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided Tissue . Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration

Prescription Use _________x_

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sign-Off)

vision of Anesthesiology, General Hospital

rection Control, Dental Devices

10(k) Number: K090950